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For Your Information: F17-09 United States of America – Prior Notice Final Rule

New Zealand Food Safety Authority
Date: 30 March 2009
From: John Lee, Market Access Counsellor (North America)

1 Final Rule Published

1.1 The Food and Drug Administration has published a final rule regarding changes to the existing Prior Notice (PN) requirements. It takes effect on 6 May 2009. The effect of the changes means that there will be an extension to some of the existing reporting times. Importers/agents in the US are primarily affected as they tend to carry out this function.

1.2 The following changes are the most significant in that the final rule increases the maximum time frame permitted to submit the PN.  In the interim rule the maximum PN time frame was 5 days prior to arrival of shipments where the final rule will permit PN to be submitted 15 days in advance if submission is made through the PN System Interface (PNSI) and 30 days if submitted via the Automated Broker Interface/Automated Commercial System (ABI/ACS).

1.3  The final rule also adds a definition for "manufacturer" which is considered the last facility (as defined in FDA premises registration rule) that manufactured/processed the food. It requires identification of the manufacturer via name and registration number (i.e. the number given under the premises registration rule), or the full address of site-specific facility and valid reason why no registration number is submitted. There were also changes impacting personal packages (e.g. those sent by courier).

1.4 Exporters might find the following link to be of interest;
http://www.fda.gov/oc/bioterrorism/bioact.html

Disclaimer: This ‘For Your Information’ is intended for use as a guideline only and should not be taken as definitive or exhaustive. NZFSA endeavours to keep this information current and accurate. However, it may be subject to change without notice. NZFSA will not accept liability for any loss resulting from reliance on this information.